DMT
8 FDA 510(k) clearances · Product code
39 daysmedian time to decision
202 days90th percentile
8clearances measured
FDA profile
- Official device name
- Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410) | Beckman Coulter, Inc. | 2000-04-10 |
| SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (K971506) | Beckman Instruments, Inc. | 1997-06-03 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (K934273) | Eastman Kodak Company | 1994-03-21 |
| ETHYL ALCOHOL ASSAY (K923783) | Diagnostic Reagents, Inc. | 1993-01-21 |
| EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (K864894) | Em Diagnostic Systems, Inc. | 1987-01-09 |
| ETHYL ALCOHOL ASSAY KIT (K843378) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-14 |
| EMIT-ST SERUM ETHYL ALCOHOL ASSAY (K810467) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL ASSAY (K802621) | Syva Co. | 1980-10-31 |
Track DMT automatically
Every clearance here is in the API, with alerts when new ones post.